Effective Dates and FDA Requirements in the FDA Food Safety Modernization Act Prepared by Hogan Lovells US LLP, February 2011

Transcription

1 in the FDA Food Safety Modernization Act Prepared by Hogan Lovells US LLP, February 2011 Provision Facility Registration Food facilities are required to register with FDA every 2 years, starting in 2012, between October and December. FDA will have to promulgate regulations to implement the section, but may do so on an interim final basis. [No date given, but likely necessary before registrations begin in October 2012.] FDA is required to issue a small entity compliance guide (SECG) within 180 days of issuance of regulations. FDA has the authority to require registration in electronic format, but not before 5 years after enactment of the bill. Preventive Process Controls (Sec. 102) Within 18 months, FDA is required to promulgate regulations establishing minimum standards for the effective implementation of this section. Prior to issuing regulations, FDA must review existing domestic and international standards to ensure consistency with such standards, as appropriate. FDA also is required to issue a guidance document related to the regulations promulgated with respect to identification and evaluation of hazards. [No date]. Within 9 months, FDA is required to issue a proposed rule clarifying the on-farm activities that would constitute manufacturing or processing. FDA is required to issue a final rule within 9 months of the close of the comment period for the proposed rule. FDA is required to issue a SECG within 180 days of enactment. FDA is required to define small business and very small business within 18 months of enactment. The preventive controls requirements take effect within 18 months of enactment for large firms, 6 months after the effective date of FDA s regulations for small firms, and 18 months after the effective date of FDA s 1

2 regulations for very small firms. Within 180 days, FDA is required to update the Seafood HACCP guidance document. The Secretary, in consultation with the USDA, must conduct a study that will be used to define the terms small business and very small business. The Secretary must submit a report to Congress that describes the results of this study within 18 months of enactment. Within 18 months of enactment, FDA must define the terms small business and very small business, taking into account the study conducted by HHS and USDA. Performance Standards Produce Safety Standards (Sec. 103) Every 2 years, FDA is required in coordination with USDA and based on studies, GMPs, and recommendations of relevant advisory committees, to review and evaluate the most significant food-borne contaminants and, when appropriate, FDA would then issue contaminant specific and science-based guidance documents including action levels, and regulations to help prevent adulteration. (Sec. 104) Within 1 year of the bill s enactment, FDA, in consultation with USDA, state departments of agriculture, and the Secretary of Homeland Security, is required to publish a notice of proposed rulemaking establishing sciencebased standards for the safe production and harvesting of those types of fruits and vegetables (including mixes or categories of fruits and vegetables) for which FDA has determined that such standards would minimize the risk of serious adverse health consequences or death (i.e., high risk ). During the proposed rulemaking comment period, FDA is required to conduct at least 3 public meetings in diverse geographical areas. A final rule is required within 1 year of the closing of the comment period. The regulations apply to small businesses 1 year after the effective date of the final regulation and 2 years for very small businesses. Within 180 days after the regulations are promulgated, FDA is required to issue a SECG. Also within 1 year of the bill s enactment, guidance must be published updating good agricultural practices. FDA is required to hold at least 3 public meetings to conduct education and outreach regarding the guidance. (Sec. 105) 2

3 Protection Against Intentional Adulteration The preventive controls requirements, which require consideration of food defense, take effect within 18 months of enactment for large firm. For small firms, they take effect 6 months after FDA s final regulations become effective for very small firms they take effect 18 months after FDA s final regulations become effective. (Sec. 103) FDA is required to promulgate regulations to protect food against intentional adulteration within 18 months after enactment. Within 1 year of enactment, FDA is required to issue guidance documents related to protection against intentional adulteration of food. Traceability (Sec. 106) Within 9 months of enactment (270 days), FDA is required to conduct pilot projects, in cooperation with the applicable food sector, to explore methods to improve the tracking and tracing of food. FDA is required to report the findings of the pilot projects to Congress, along with recommendations for improving the tracking and tracing of food, within 18 months of enactment. After completion of the pilot projects, FDA is required to establish within the agency a product tracing system to receive information to track and trace food. [No date.] Within 2 years of enactment, FDA is required to publish a proposed regulation covering the recordkeeping requirements associated with product tracing of high risk foods, to be followed by at least 3 public meetings to obtain input from different regions of the country. At the time the final rule is promulgated [no date], FDA is required to publish a list of the foods designated as high-risk on its website. Within 1 year of enactment, FDA is required to designate high risk foods for which the additional recordkeeping requirements are appropriate. Within 1 year of enactment, the GAO is required to submit a report to Congress evaluating the benefits and risks of limiting product tracing requirements to high-risk foods and of limiting the participation of restaurants. Small and very small businesses have one additional year to comply with any final regulations and very small businesses have an additional 2 years to comply. FDA also is required to issue a SECG within 180 days of promulgation of the final rule. (Sec. 204) 3

4 Inspection Frequency Domestic high-risk facilities must be inspected at least once in the 5-year period following enactment and at least once every 3 years thereafter. The remaining domestic facilities must be inspected at least once in the 7-year period following enactment and at least once every 5 years thereafter. FDA must inspect at least 600 foreign facilities in the year after enactment and at least twice the number inspected during the previous year in each of the 5 years thereafter (e.g., 9600 facilities in the 5 th year, 19,200 in the 6 th year). FDA is required to submit an annual report to Congress regarding inspection frequency and whether the agency is meeting the mandated frequency requirements. Record Keeping and Records Access (Sec. 201) Effective immediately, under the emergency access provision of the Bioterrorism Act, FDA has access to and is able to copy all records relating to an article of food, and all related articles of food, if it has a reasonable belief that such foods present a threat of serious adverse health consequences or death. (Sec. 101). FDA will have access to food safety plans and related documents 18 months after enactment. (Sec. 103) Imports Foreign Supplier Verification Program Imports Expedited Entry Imports Third Party Certification Within 1 year of enactment, FDA is required to issue guidance on the development of foreign supplier verification programs and promulgate regulations regarding the content of these programs. The amendments relating to the foreign supplier verification program are effective 2 years after the date of enactment. (Sec. 301) Within 18 months of enactment, FDA is required to establish, in consultation with DHS, a program for expedited review and importation of products from importers voluntarily participating in a qualified importer program. (Sec. 302) Within 18 months of enactment, FDA must issue model standards that accrediting bodies should ensure auditors meet. Within 2 years of enactment, FDA must implement a system whereby it would recognize accreditation bodies that accredit third-party auditors. 4

5 Within 18 months of enactment, FDA is required to issue regulations regarding conflicts of interest for third-party auditors. Imports Laboratory Testing Imports Prior Notice (Sec. 307) Within 2 years of enactment, FDA is required to provide for the recognition of accreditation bodies that accredit laboratories and to establish a publicly available registry of recognized accreditation bodies and accredited labs. Within 30 months of enactment, either federal labs or labs accredited by an accreditation body on FDA s registry are required to be used for all food testing in support of admission of an imported food and other designated purposes. (Sec. 202) Within 120 days of enactment, the FDA is required to issue an interim final rule regarding prior notice of rejections by another country of an imported food. This section is effective 180 days after the date of enactment. Imports Foreign Inspectorate Imports Building Capacity of Foreign Governments Imports -Smuggled Food (Sec. 304) By October 1, 2011, the bill would require FDA to submit a report to Congress describing the process and progress in establishing offices in foreign countries. (Sec. 308) FDA, within 2 years of enactment, must develop a plan to expand the technical, scientific, and regulatory capacity of foreign countries exporting food to the United States. (Sec. 305) Within 180 days of enactment, in consultation with DHS, FDA must develop and implement a strategy to better identify and prevent the entry of smuggled food. (Sec. 309) 5

6 Unique Facility Identification Number Suspension of Registration Notification and Reporting Within 1 year of enactment, FDA is required to conduct a study on the need for and challenges associated with requiring unique facility identification numbers for each registered food facility and import broker. FDA is required to submit to Congress a report regarding the results of the study within 15 months of enactment. (Sec. 110) FDA is required to promulgate regulations describing the standards used in deciding to suspend a registration. FDA may promulgate the regulations on an interim final basis. Suspension of registration can take effect the date that FDA issues such regulations, or 180 days after enactment, whichever is earlier. (Sec. 102) Within 18 months of enactment, FDA is authorized to require a responsible party to submit consumer-oriented information regarding a reportable food to the Reportable Food Registry, including a description of the food, the affected product identification codes, and contact information for the responsible party. Within 1 year of enactment, FDA is required to develop a list of acceptable locations from which grocery stores would chose one to provide the required consumer notification. Mandatory Recall Authority (Sec. 211) Within 90 days of enactment, FDA is required to establish a web-search engine to allow consumer access to information regarding a food that is subject to a mandatory recall. Within 2 years of enactment and annually thereafter, FDA is required to provide a report to Congress identifying when the agency used the mandatory recall authority and the circumstances by which the agency concluded that the situation warranted use of such authority. GAO is directed to provide a report to Congress within 90 days of enactment reviewing state and federal mandatory recall authority and the mechanisms available to compensate parties for wrongfully ordered recalls. Within 90 days of the report, USDA is directed to conduct a study on the ability to implement a farmer restitution program. (Sec. 206) 6

7 Administrative Detention Fees Recalls Within 120 days of enactment, FDA is required to issue an interim final rule implementing this provision. This section becomes effective in 180 days. (Sec. 207) FDA is authorized to assess fees for facilities that conduct mandatory recalls. Within 180 days after enactment, FDA would be required to publish guidelines in consideration of the burden of fee amounts for small businesses. FDA must provide for a period of public comment on the guidelines. FDA must establish mandatory recall fees for each fiscal year and must publish the fees in a Federal Register notice at least 60 days before the start of each such year. Fees must be provided for by Congress in the appropriations process. Fees Reinspection Fees Voluntary Qualified Importer Export Certificates (Sec. 107) Within 180 days after enactment, FDA would be required to publish guidelines in consideration of the burden of fee amounts for small businesses. FDA must provide for a period of public comment on the guidelines. FDA is authorized to establish reinspection fees for each fiscal year and must publish the fees in a Federal Register notice at least 60 days before the start of each such year. Fees must be provided for by Congress in the appropriations process. (Sec. 107) FDA is authorized to assess fees for importers participating in the voluntary qualified importer program. FDA must establish such fees for each fiscal year and must publish the fees in a Federal Register notice at least 60 days before the start of each fiscal year. Fees must be provided for by Congress in the appropriations process. (Sec. 107) FDA is authorized to assess fees for export certificates. Fees must be provided for by Congress in the appropriations process. (Sec. 107) 7

8 Food Defense Strategy Food and Agriculture Coordinating Councils Domestic Capacity Within 1 year of enactment, HHS and USDA, in consultation with DHS, are required to submit to Congress a National Agriculture and Food Defense Strategy. Every four years, a revised plan must be submitted to Congress. (Sec. 108) Within 180 days of enactment and annually thereafter, USDA, FDA, and DHS are required to submit a report to Congress on the activities of the Food and Agriculture Sector Coordinating Council and the Government Coordinating Council. (Sec. 109) Within 2 years of enactment, FDA, in coordination with USDA and DHS, is required to submit a report to Congress identifying its food safety programs and practices. Thereafter, FDA is required to submit a report on a biennial basis reviewing previous food safety programs and practices and identifying future ones. On a biennial basis, FDA is required to submit a food safety and food defense research plan to Congress. Also, FDA is required to evaluate the effectiveness of its programs and report to Congress on this evaluation within 1 year of enactment. Sanitary Transportation of Food Food Allergy and Anaphylaxis Management Integrated Consortium of Laboratory Networks (Sec. 110) Within 18 months of enactment, the bill requires FDA to promulgate regulations regarding the sanitary transportation of food. (Sec. 111) Within 1 year of enactment, the Secretary of Health and Human Services, in consultation with the Secretary of Education, is directed to develop voluntary, food allergy management guidance to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. (Sec. 112) FDA, in coordination with USDA and DHS must submit periodic reports to Congress on the implementation of the food emergency response network of laboratories. (Sec. 202) 8

9 Surveillance New Dietary Ingredients Training Within 1 year of enactment, FDA is required to review state and local capacities for food safety and food defense functions. (Sec. 205) Within 180 days of enactment, FDA is required to issue guidance clarifying what constitutes a new dietary ingredient, when a new dietary ingredient notification is necessary, and the evidence needed to document the safety of the ingredient. (Sec. 113) Within 180 days of enactment, FDA is required to enter into memoranda of understanding with USDA to establish a competitive grant program to provide training and education to farm, small processors and small fruit and vegetable wholesalers. (Sec. 209) Within 1 year of enactment, CDC must establish 5 Integrated Food Safety Centers of Excellence to serve as resources for federal, state, and local public health professionals to respond to foodborne illness outbreaks. Within 180 days of enactment, the Secretary must establish a working group of food safety experts to make recommendations regarding designations of the Centers of Excellence. Within 2 years of enactment, the Secretary must submit a report to Congress regarding the effectiveness of the centers. (Sec. 210) 9